Primary-source record

Decision-gradeTopline results

Lilly Omvoh (mirikizumab) hits primary endpoint in Phase 3 SHINE-2 pediatric UC study

Lilly reported positive one-year Phase 3 SHINE-2 topline results for Omvoh in pediatric patients ages 6-17 with moderately to severely active ulcerative colitis. Among Week 12 responders, 50% achieved clinical remission at Week 52 (primary endpoint), meeting a pre-specified benchmark. Lilly plans to submit these data to regulators to support a potential pediatric label expansion.

Key facts

Filed
Oct 19, 2026, 04:40 PM
Event
Topline results
Direction
Positive
Confidence
Sourced
clinical response
81% induction, 73.1% at 1yr
clinical remission
50%
symptomatic remission
71.2%
corticosteroid free clinical remission
50%

Source excerpt

Lilly's Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis Lilly's Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis USA - English APAC - English APAC - Traditional Chinese India - English Indonesia - Bahasa APAC - Thai Vietnam - Vietnamese Korea - 한국어 APAC - Malay News provided by Eli Lilly and Company Oct 19, 2026, 04:40 ET Share this article Share to X Share this article Share to X Building on Omvoh's approved use and durable efficacy in adults, Lilly plans to submit these data to global regulators to support a potential label expansion for pediatric ulcerative colitis More than 80% of patients responded to Omvoh induction, and half of responders, ages 6 to 17, were in clinical remission at one year in Phase 3 SHINE-2 study In key secondary outcomes, 71.2% of patients who responded to Omvoh induction achieved symptomatic remission and 50% achieved corticosteroid-free clinical remission at one year without surgery INDIANAPOLIS , Oct. 19, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) today announced positive late-breaking one-year results from the Phase 3 SHINE-2 study of Omvoh (mirikizumab-mrkz) in pediatric patients ages 6 to 17 with moderately to severely active ulcerative colitis (UC), including clin

Company press release

More on this asset

Oct 15, 2026
08:00 PM
LLYEli Lilly

Lilly Omvoh post-hoc LUCENT/VIVID data to be presented at UEG Week 2026

Conference presentationCompany press release
Lilly Omvoh (mirikizumab) hits primary endpoint in Phase 3 SHINE-2 pediatric UC study | SimianX AI